Kornimate/medical-research-clean huggingface dataset:
passive safety surveillance data of dengue vaccine, qdenga (tak 003) in private vaccination sites in buenos aires, argentina.

Conditions: Dengue Vaccines

Summary: the tak-003 vaccine, qdenga, developed by takeda, was approved by anmat in april 2023 and has been available in argentina since november 2023 for individuals from 4 years old and without limit of age. clinical trials demonstrate that qdenga has a favorable safety profile, adequate immunogenicity for all four serotypes, and efficacy in preventing severe dengue in seropositive and seronegative subjects. however, there are currently limited real-world safety studies on tak-003, particularly for adults over 60 years old. the aim of this study is to evaluate adverse events supposedly attributed to vaccination and immunization (aefi) for tak-003 vaccine in vaccinated people at private vaccination centers in buenos aires metropolitan area.


Eligibility criteria:
inclusion criteria: * all individuals who were vaccinated with qdenga at vacunar centers since november 2023 still 1st november 2024, from 4 years of age with no upper limit in accordance with anmat approval and for whom safety data is available through the vacunar centers passive surveillance systems. exclusion criteria: * reports with insufficient information to characterize the aefi will be excluded from the analysis.

Keywords: dengue vaccine safety passive surveillance aefi tak-003 argentina
a pilot study comparing tolerance of oral heme iron polypeptide with oral ionic iron

Conditions: Iron Deficiency

Summary: this is a pilot study designed to compare the tolerance of ionic iron (ferrous sulphate) with heme iron polypeptide. subjects will take one week of one product followed by a week with no product followed by a week with the other product. subjects will complete a daily diary to assess side effects. hypothesis: heme iron polypeptide is associated with fewer gastrointestinal side effects than ionic iron.

iron deficiency anemia (ida) is a worldwide problem in both children and adults. traditional ionic oral iron supplements have many disadvantages including high gastrointestinal side effects, poor and variable absorption, poor compliance, and the potential for overdose, especially in children. proferrin is a currently available form of heme iron polypeptide (hip). it is different from older more traditional iron formulations, such as ferrous sulphate, in that it is heme iron as opposed to ionic iron. the porphyrin ring of heme allows the iron to be absorbed through a different receptor than ionic iron resulting in different absorption kinetics and gi side effect profiles. the absorption of hip is via the same mechanism as dietary iron contained in meat. therefore, heme iron therapy may avoid several problems associated with ionic iron therapy such as gastrointestinal side effects and absorption that is dependent on food intake. 30 subjects will be enrolled, randomized to starting with one or the other study drug, but crossing over to the other, so that all subjects will be in a single cohort. this is an open label randomized pilot study intended to test the feasibility of collecting information on drug tolerance. the randomization will be stratified by age, gender and hemoglobin. an optional baseline blood test will be drawn (cbc, iron profile, ferritin). if subjects decide to participate in the optional blood draws, they will return during the week they are not taking either study medication for this test. for subjects not participating in the optional blood tests and not needing to return to the clinic for another reason, subjects will be contacted by phone (or in person if returning to the clinic for another reason) during the week not taking either medication to address any concerns or issues. if not agreeing to participate in the blood tests, they will be allowed to send the empty pill bottles and the diary by mail and will be contacted by phone to make sure there were no problems during the study. if participating in the optional blood tests, within one month after taking the final pill, subjects will return to the clinic to return the medication containers and study diary.

Eligibility criteria:
inclusion criteria: * able to fill out daily diary exclusion criteria: * known iron overload * sensitivity to either product used
electrolyte and fluid disturbances in subarachnoid hemorrhage and traumatic brain injury

Conditions: Electrolyte Disturbances; Subarachnoid Hemorrhage; Traumatic Brain Injury; Natriuretic Peptides

Summary: during the course of their acute illness patients with subarachnoid hemorrhage and severe traumatic brain injury often develop disturbances in their fluid balance and electrolyte homeostasis. these shifts are associated with worse outcome and increased morbidity. the aim of this observational study is to systematically analyze the incidence, characteristics, potential diagnostic markers and predisposing factors of such disturbances. the investigators hypothesize that many disturbances cannot be classified with a standard diagnostic approach and that variable fluid management contributes to their pathophysiology. patients will be closely monitored clinically and the exact fluid and electrolyte balances will be recorded. treatment decisions are within the bedside physicians responsibility. baseline fluid management is standardised. no interventions are planned. the observation period equal the duration of icu stay.

background electrolyte disturbances and fluid shifts are common in patients with subarachnoid hemorrhage (sah) or traumatic brain injury (tbi). they usually have a rapid onset with impact on morbidity (possibly mortality) and length of stay. so far the understanding of underlying pathophysiologies and the contribution of iatrogenic influences is not fully understood. only limited evidence and data on classification, management and outcome of patients exists. objective to describe the incidence, characteristics and duration of sodium and fluid disturbances in patients with sah or tbi. to document exact fluid and electrolyte management to evaluate predisposing factors and potential predicting biomarkers such as natriuretic peptides, renin-aldosterone system. methods prospective systematic observational study with 50 patients in the sah group and 50 patients in the tbi group. 8hourly clinical assessment, blood and urin samples. defined trigger points for additional measurements. continuous fluid balance documentation daily measurement of natriuretic peptides, aldosterone and renin

Eligibility criteria:
inclusion criteria: * non-traumatic subarachnoid hemorrhage * severe traumatic brain injury (gcs\<9) exclusion criteria * younger than 18 years * time to admission after injury or bleed more than 7days * death expected in less than 12hours

Keywords: electrolyte disturbances fluid balance subarachnoid hemorrhage traumatic brain injury cerebral salt wasting siadh diabetes insipidus
progressive muscle relaxation and cigarette craving

Conditions: Addiction

Summary: cigarette craving usually occurs with unpleasant feelings, including stress. progressive muscle relaxation (pmr) may reduce level of cigarette craving and/or withdrawal symptoms.

the study reports on a study investigating the acute effects of a one-time application of progressive muscle relaxation on craving for cigarettes in smokers who were instructed to abstain from cigarettes for 3 hours.

Eligibility criteria:
inclusion criteria: * age 18 years or more * daily cigarette smokers exclusion criteria: * hospitalization * participating in cigarette dependency treatment or trying to quit smoking with other methods * uncontrolled blood pressure * current other substance users (except alcohol)

Keywords: progressive muscle relaxation cigarette smoking craving
interface kinematics of transhumeral prosthetic sockets using xromm

Conditions: Traumatic Amputation of Arm

Summary: the purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization. the investigators comparisons included assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using x-ray reconstruction of moving morphology (xromm) a novel high-speed, high-resolution, bi-plane video radiography system.

in the past decade, advances in upper limb socket design and technology have been proposed to increase comfort and decrease perceived weight of the prosthesis. there have been no scientific studies to date that have evaluated the benefits of these designs, and thus no evidence to support use of one type of prosthetic socket design over another. thus, the overall purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization.

Eligibility criteria:
inclusion criteria: * male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users. exclusion criteria: * subjects with frozen shoulder of the residual side, and/or severely limited active range of motion of the shoulder joint of the residual limb * inability to tolerate wearing of a prosthetic socket * mental impairment that renders a subject unable to comply with the study * skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevent prior prosthetic wear * any electrically controlled medical device including pacemaker, implanted defibrillator or drug pumps * neuropathy, uncontrolled diabetes, receiving dialysis * any other significant comorbidity which would interfere with the study * severe circulatory problems including peripheral vascular disease and pitting edema will be excluded * cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol * women who are pregnant or who plan to become pregnant in the near future

Keywords: amputation prosthesis design biomechanics
hpv as a possible cause of azoospermia

Conditions: HPV in Testis Tissue

Summary: azoospermia is found in 5-20% of all men suffering from infertility, and in more than 20% azoospermia remains unexplained. the investigators suggest, that hpv may be an etiological factor in azoospermia and reduced sperm production. the investigators plan to examine the occurrence of hpv in testicular tissue from 100 azoospermic men and to compare with the hpv occurrence in testicular tissue from a control group of 40 normal, healthy men undergoing vasectomy. since hpv, in a recent danish study, was detected on sperm in 16% of 188 randomly selected semen donors, the investigators also plan to examine the occurrence of hpv on sperm ejaculated during the last week before vasectomy. if hpv should be found in testicular tissue from men belonging to the control group, it will be highly relevant to compare with the hpv occurrence on sperm ejaculated from the men in concern. a linear array hpv genotyping kit from roche will be used for detection of hpv in testicular tissue and ejaculates. in total, with this test kit 37 hpv genotypes are examined for, including 13 high risk types.


Eligibility criteria:
inclusion criteria: * men with azoospermia (group 1) and proven fertile men undergoing vasectomy (group 2) exclusion criteria: * men with testicular abnormalities (group 2) * men who do not understand the purpose and possible consequences of the study (both groups)
analgesic effect of esketamine in dcsb in adultscontrolled study

Conditions: Analgesia; Burns

Summary: patients with severe and above degree burns are often complicated with inhalation injury and systemic infection. during debridement and dressing change in such patients, doctors will be more cautious in using analgesics. patients often moan, shiver and limb movement due to insufficient sedation and analgesia, resulting in unpleasant feelings and experiences, which increases the anxiety of patients during hospitalization. previous studies have shown that the use of ketamine in burn patients during dressing change can produce good analgesia and maintain stable vital signs. esketamine, the dextral monomer of ketamine, has hypnotic, sedative and analgesic effects and could be safely used in clinical anesthesia. compared with ketamine, esketamine has stronger analgesic efficacy and less circulatory influence, which is more consistent with the characteristics of ideal analgesic drugs in burn dressing. as an fda-approved drug for the treatment of refractory depression, esketamine has potential social benefits in burn patients due to its rapid antidepressant pharmacological properties. this study hypothesized that esketamine could reduce the pain of dressing change in patients with severe burns and reduce the occurrence of early depression in such patients. this study adopted a prospective, double-blind, randomized, controlled, single-center design. a total of 52 severe burn patients aged 18-60 years who need debridement and dressing change under sedation and analgesia were included and randomly divided into the experiment group: esketamine would be used in the induction phase; the control group: esketamine would not be used in the induction phase. both groups were given dexmedetomidine and butofinol before induction, and fentanyl as a remedy during the dressing change phase. the dosage of fentanyl in the dressing change phase, the pain score (sf-mpq) after recovery, the incidence of sedation-related complication were compared between the two groups. this study explores the advantages of esketamine in reducing the use of opioids and the pain score of patients.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) grades ii to iv * patients with severe degree burns ages 18 to 60 * patients who signed informed consent forms exclusion criteria: * hepatic and renal insufficiency * allergy to intended medication * history of antidepressant or antipsychotic drug use * atrioventricular block of second degree or higher * patients who can't cooperate

Keywords: analgesia burn dressing change esketamine fentanyl adverse events
gr1803 injection in patients with rrmm

Conditions: Multiple Myleoma

Summary: all subjects will receive gr1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.


Eligibility criteria:
inclusion criteria: * 1、ecog score 0-2 2、≥18 years of age 3、multiple myeloma must be complicated by extramedullary plasmacytoma. exclusion criteria: * 1、prior treatment with any bcma-targeted therapy 2、known active cns involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、plasma cell leukemia , waldenström's macroglobulinemia, poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
a efficacy and safety study of adefovir dipivoxil to treat chinese patients with hbeag+ve chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to determine whether adefovir dipivoxil is effective and safe in treatment of chinese patients with hbeag positive chronic hepatitis b for 5 years.


Eligibility criteria:
inclusion criteria: * aged 18-65 years * presence of hbsag and hbeag at the time of screening and for at least 6 months prior to screening. * positive hbv dna plasma assay with screening value equal or more than 10 (6) copies/ml (roche cobas amplicortm hbv monitor test, llod less than 300 copies/ml) at the time of screening (within 4 weeks of randomisation). * evidence of elevated serum alt levels defined as serum alt level greater than or equal to 2.0 times (inclusive) the upper limit of the normal range (uln) in the previous 6 months, and serum alt levels greater than 1.0 times the uln at the time of screening. exclusion criteria: * evidence of hepatocellular carcinoma; * clinical signs of liver decompensation; * serum creatinine more than 1.5 mg/dl; * alt more than 10 x uln; seropositivity for hepatitis c or d virus or hiv; * lamivudine therapy within 3 months prior to screening; * adv therapy or any other anti-hbv therapy within the previous 6 months; * use of systemic antiviral agents, immunomodulators, immunosuppressive therapy, chinese traditional medicines or agents known to lower alt levels during the study.

Keywords: hbv dna suppression alt normalisation viral resistance hbeag seroconversion
heart leaflet technologies valve study

Conditions: Aortic Valve Stenosis; Endovascular Aortic Valve Replacement

Summary: the study will be conducted in patients who are undergoing surgical aortic valve replacement on cardiopulmonary bypass. following surgical access of the native aortic valve and prior to removal of the valve, the native valve will be dilated using a standard valve dilation balloon. the heart leaflet technologies(hlt- heart leaflet technologies inc.) aortic valve device will be released in the native valve and measurements will be taken of the device relative to the anatomic structures of the heart. once completed, the implant is removed from the native valve and the surgical valve replacement procedure is completed. the purpose of this study is to confirm that the dimensions of the hlt valve are appropriate for patients with aortic valve stenosis.

aortic valve stenosis is a disease in which the leaflets of the aortic valve become scarred and calcified. this leads to a severe narrowing of the valve orifice, which causes chest pain, heart failure and eventually death. the condition is currently treated with open chest surgical valve replacement on cardiopulmonary bypass. heart leaflet technologies has developed an aortic valve prosthesis that can be delivered to the stenotic aortic valve through a catheter inserted in the femoral artery. the purpose of this study is to confirm that the dimensions of the hlt valve are appropriate for patients with aortic valve stenosis. there is no animal model of aortic valve stenosis. heart leaflet technologies has performed extensive device geometry and deployment testing on fixed cadaveric hearts with calcified cusps and aortic stenosis. hlt has also performed a number of preclinical animal experiments to verify deliverability and device function in vivo.

Eligibility criteria:
inclusion criteria: 1. patients undergoing aortic valve replacement for aortic valve stenosis with a preoperative valve area \< 0.9 cm2. 2. a preoperative echocardiogram where the aortic annulus diameter can be measured and is between 19 and 25 mm internal diameter. 3. age 75 to 80 years exclusion criteria: 1. emergency valve surgery 2. significant ascending aortic disease (atheroma, extensive calcification, dissection) as assessed by the operating surgeon 3. ostial coronary obstruction \> 25% diameter stenosis

Keywords: aortic valve stenosis heart surgery endovascular techniques
biofeedback treatment of anxiety associated with chronic spinal cord injury

Conditions: Spinal Cord Injuries; Anxiety; Stress; Tetraplegia

Summary: the purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia. the expected duration of participation in this study is about 5 hours over the course of about 5 weeks. participants will be randomly assigned to either a biofeedback training intervention or a control group. after completing questionnaires, participants will undergo physiological monitoring for the purpose of measuring heart rate and breathing. those assigned to the biofeedback group will undergo 20 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home. those assigned to the control group will undergo 20 minutes of physiological monitoring twice a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. each session is expected to last 30 minutes to allow for completion of questionnaires over the the phone prior to and following each training session. it is hypothesized that the biofeedback intervention will demonstrate high feasibility and compared to those in the control group, participants who receive the biofeedback intervention will attain greater pre-post reductions in both physiological and self-reported stress.


Eligibility criteria:
inclusion criteria: * age 18 to 65 * diagnosis of tetraplegia with residual sensory or motor impairments * discharged from inpatient rehabilitation and living in the community * access to high-speed internet at home * willingness to download the videoconferencing software zoom * access to a mobile phone and willingness to download hrv software exclusion criteria: * does not speak english * scores less than 37 on the stai * unable to travel to craig for an initial assessment * history of participating in biofeedback training * requires mechanical ventilation * dependent on diaphragm pacer for respiration * currently in treatment for anxiety (e.g., pharmacologic or psychotherapeutic) * associated medical condition for which biofeedback is contraindicated (e.g., psychosis, pacemaker, or other implantable electric device) * currently hospitalized for medical/rehabilitation treatment * unable to commit to the four-week intervention